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Sponsors and Collaborators: |
Stanford University National Institutes of Health (NIH) Genzyme |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00568633 |
Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.
Condition | Intervention | Phase |
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Leukemia, Myeloid |
Procedure: Hematopoietic Cell Transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-Thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission |
Estimated Enrollment: | 150 |
Study Start Date: | August 2007 |
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Both genders and individuals from all ethnic groups will be eligible.
2. Patients not in a Complete Remission at time of enrollment.
3. Patients with treatment-related or MDS-related AML.
4. CR documented >8 weeks prior to date of enrollment.
5. Patients with active CNS disease as identified by positive CSF cytospin at time of enrollment.
6. Patients with prior or concurrent malignancies except localized non-melanoma skin malignancies or treated cervical carcinoma in situ. Cancer treated with curative intent <5 years previously will not be allowed. Cancer treated with curative intent >5 years previously will be allowed. Patients with low grade lymphomas are eligible as long as they have not and do not require active treatment for control of their disease.
7. Patients planned for allogeneic transplant using a full-dose conditioning, irrespective of knowledge of donor status.
8. Patients whose life expectancy is severely limited (<1 year) by diseases other than malignancy.
9. Karnofsky Performance Score <60.
10. Patients who are pregnant or breastfeeding.
11. Patients who are HIV seropositive.
12. Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month.
13. Patients with symptomatic coronary artery disease, uncontrolled congestive heart failure. Left Ventricular Ejection Fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is <30%.
14. Patients requiring supplementary continuous oxygen. DLCO is not required to be measured, however if it is measured, patient is excluded if DLCO <35%.
15. Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension. Patients with any of the following liver function abnormalities will be excluded:
United States, California | |
Southern California Kaiser Permanente Group | Recruiting |
Hayard, California, United States | |
Contact: Louis Fehrenbacher 707-651-2577 | |
Principal Investigator: Louis Fehrenbacher | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: BMT Referrals 650-725-1647 | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Robert Lowsky | |
Sub-Investigator: Sally Arai | |
Sub-Investigator: Jason Robert Gotlib | |
Sub-Investigator: Laura Johnston | |
Sub-Investigator: Ginna Laport | |
Sub-Investigator: Bruno Carneiro de Medeiros | |
Sub-Investigator: David Miklos | |
Sub-Investigator: Robert S Negrin | |
Sub-Investigator: Judith Anne Shizuru | |
Sub-Investigator: Wen-Kai Weng |
Principal Investigator: | Louis Fehrenbacher | Southern California Kaiser Permanente Group |
Principal Investigator: | Robert Lowsky | Stanford University |
Study ID Numbers: | SU-11122007-874, 97843, BMT190, NCT00568633 |
Study First Received: | December 4, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00568633 |
Health Authority: | United States: Institutional Review Board |
Antilymphocyte Serum Leukemia Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |